Fetal congenital diaphragmatic hernia
Conditions
Interventions
A thin walled flexible Teflon cannula (3.3 mm
Performa, Cook, Strombeek Bever, Belgium), loaded with a pyramidal trocar (11650TG, Karl Storz, Germany) should be inserted into the amniotic cavity towards the fetal mouth. The trocar should then be
s solution heated to body temperature, for improving visualization and assist in dilatation of the vocal cords on entry of the trachea. The endoscope should be introduced into the fetal mouth, followi
Balt, Paris, France). Balloon retrieval should be planned at between 34+0 and 34+6 weeks. The options are ultrasound guided puncture and fetoscopic retrieval.
Sponsors
Japan Fetal Therapy Group (Fetus Japan)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Between 27 and 31 weeks of gestation 2) Pregnant woman who is between 16 to 45 years old 3) Diagnosed as singleton with left sided isolated CDH 4) Diagnosed as left sided CDH with Liver up in the chest cavity and Stomach mainly in the right chest cavity (Grade 3 of Kitano classification) 5)O/E LHR < 45% 6) No other presence of fetal anomaies 7) No sign of pregnancy induced hypertension 8) No genital bleeding 9) No premature rupture of membrane 10) Greater than or equal to 20 mm of cervical length 11) Agreement of patient and her partner to follow the protocol
Exclusion criteria
Exclusion criteria: 1) Pregnant woman needs treatment for infectious disease. 2) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women 3) Pregnant woman needs treatment for psychological problems 4) American Society of Anesthesiology (ASA) Physical Status Classification: Class 3, 4, 5, or 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Complete FETO procedures without serious maternal side effects 2) survival till 90 postnatal days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Developmental milestones at 6 months after birth 2)Neurodevelopmental milestones at 6 months after birth 3)Adverse effects during FETO procedures 4)Unfixed balloon during and after FETO procedures 5)Lung size after FETO 6)Liver position after FETO 7)Stomach position after FETO 8)Preterm delivery after FETO 9)Intra-uterine fetal demise after FETO 10)Survival after FETO 11)Discharge without any serious complications 12)Number of days in neonatal intensive care unit after birth 13)Number of days of ventilatory support 14)Number of days of NO treatment 15)Complete surgery 16)Any other additional side effects | — |
Countries
Japan
Contacts
Public ContactSeiji Wada MD PhD
National Center for Child Health and Development Department of Fetal Therapy
Outcome results
None listed